MAUDE Adverse Event Report: SPECTRANETICS CORPORATION TURBO-ELITE LASER ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 410-152

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 08/01/2023

Event Type  malfunction  

Event Description

A peripheral atherectomy procedure commenced, and a spectranetics turbo-elite laser atherectomy catheter was used to treat the patient.Initial calibration of the catheter went smoothly and performed normally.Upon removal, flaking was reported at the tip of the catheter.Use of the catheter was discontinued, and another laser catheter was used to complete the procedure with no reported patient harm.During initial device evaluation, a missing portion of the outer jacket was noted, and exposed fibers were present in the area.The evaluation and investigation are currently ongoing.This event is being reported for unintended radiation exposure, potential for harm.

Manufacturer Narrative

H3/h6): the device was returned to the manufacturer and the evaluation is currently ongoing.A supplemental mdr will be submitted upon completion of the device evaluation and investigation.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• Brand Name: TURBO-ELITE LASER ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 18504521
• MDR Text Key: 333329913
• Report Number: 3007284006-2024-00008
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)230812(10)FBD21H04A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2023
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD21H04A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE MANUFACTURER/SIZE UNK.; INTRODUCER SHEATH MANUFACTURER/SIZE UNK.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.